# K220063: Single Use Cytology Brush

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Decided: Jul 28, 2022 after 199 days
- Product code: FDX (Endoscopic Cytology Brush)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K896318 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172663: Cytology Brush, Micro-Tech (Nanjing) Co., Ltd. (2018) Summary page 4.

## Indications for use
This device is used to enter human gastrointestinal tract (stomach or duodenum) via endoscope to collect cells.

Source page: https://510kreport.com/device/K220063
Methodology: https://510kreport.com/methodology